Non-drug therapies can be classified as invasive and non-invasive procedures. Non-invasive procedures do not employ surgery and have several attractive features over invasive surgical procedures. They do not cause damage to biological tissues, do not result in skin injury, do not cause bleeding, blood clotting, infection or internal organ injury and hence are less risky. They do not require drugs or local anesthesia, so are painless. They do not require skilled surgeons, do not need extended stay in hospitals or long recuperative time in bed and so are less expensive. In view of the lower risk, pain and cost benefits, patients are increasingly favoring non-invasive treatments over surgical procedures.
A non-invasive procedure of particular interest is pulsed magnetic stimulators that inject magnetic fields into target nerves, blood vessels or tissues, inducing currents that release neurotransmitters to treat various disorders. The ionic current pulses can also synthesize curative molecules in tissues. This operating mechanism is similar to ECT or defibrillators, but they differ in that they inject magnetic fields instead of current. Changes in magnetic fields induce currents so have the same ultimate effect. Prior art has developed several stimulators but none of them are wearable as discussed below.
FIG. 5 illustrate a few prior-art magnetic stimulator heads. FIG. 5A shows a prior art “Neocon chair” 42 (developed by Neotonus Inc. GA) as described in U.S. Pat. Nos. 6,086,525 and 6,500,110 and is used to treat incontinence. The patient 41 sits in a chair 42 with her pelvic bottom 50 resting on a chair 43 containing a stimulator head 44 that produces magnetic field 46, which stimulates pelvic floor nerves 48. The stimulator head 44 is a large-gapped iron-cored electromagnet as described in U.S. Pat. Nos. 5,725,471, 6,086,525 and U.S Pat. Pub. 20020097125, is too heavy so is non-wearable. Per U.S. Pat. Pub. 20110125203, the stimulator controller delivers ˜5.000 amps, so is very large, heavy and non-wearable. Thus, the Neocon chair 42, the magnetic stimulator head 44 and the stimulator controller are too heavy and non-portable so are non-wearable.
FIG. 5B, inset (a) shows another prior-art stimulator head 52 (developed by Neotonus Inc, GA) that is used to treat knee muscle problems as described in U.S. Pat. No. 5,725,471. Known as Neotone™, the stimulator head 52 also employs a large-gapped C-core; a technician holds it close to the knee 54 spaced by an air gap 58. The head radiates magnetic fields 56, which induce currents in blood vessels to start the healing process. Both the large-gapped stimulator head 52 and its controller are too heavy and hence non-wearable.
FIG. 5B, inset (b) shows an alternative air-cored stimulator head 62 as described in U.S. Pat. Appln. 20120302821 that is used to treat ankle muscles. This stimulator head 62 is secured to the knee 54 by a wrap 64 to stimulate tibial nerve 57. Although this head appears to be wearable, it demands very large currents that could overheat the knee 54 and cause skin burns.
FIG. 5C shows another air-cored stimulator head 72 atop the wrist 390 to treat wrist injuries, as in U.S. Pat. No. 5,078,674. The stimulator head 72 is a petal shaped, near-circular coil with sharp corner 76 and rests on the skin 395 of the patient. The sharp corners cause flux concentration which results in higher neuron depolarization. However, the stimulator head 72 atop the hand is not wearable. The associated stimulator controller generates thousands of amperes so is too large and heavy to be worn by a patient, and hence is non-wearable.
FIG. 5D shows another prior art electrical stimulator head Gammacore® 82 (developed by Electrocore, NY) described in U.S. Pat. Appln. 20120101326 and is used to treat migraine headaches and. It is a hand-held device comprising iron-cored toroids with two electrodes 87, 88 at the ends. The patient 90 holds the stimulator head 82 in his hands 89 and presses it against the vagus nerve 84 which is located in the left side at bottom of the neck. This manufacturer also produces another electrical stimulator head Alphacore® described in U.S. Pat. Appln. 20110125203 to treat incontinence. Both Alphacore® and Gammacore® are handheld electrical stimulators (not magnetic stimulators) as they apply currents to electrodes near the nerves. Even though they are portable and handheld, they are very large, heavy and require hands to hold, so are non-wearable.
Prior-art has also developed several air-cored magnetic stimulator heads and used them to treat Spinal Cord Injury (SCI). The patient positions them at upper, middle or lower portions of spinal cord such as C3 to C5. However, they are also very large and require a heavy stimulator controller, so are non-wearable. V. Lin in Spinal Cord Medicine: Principles and Practice, pp. 749-755, 2003 published a comprehensive survey of such air-cored stimulators. Per this survey, air-cored stimulators are as large as 90 to 120 mm so are non-wearable. They require heavy and large pulse generators with ˜5000-amp capacity. U.S. Pat. Appln. 201220302821 describes a wearable air-core stimulator head that is built into underwear. However, it requires a stimulator controller that is too large and heavy, so the system is non-wearable. Thus all these prior art stimulators employed large-gapped cores, they require large and heavy controllers so are non-wearable.